Standard description on Senior Regulatory Executive Template
- Preparation of high quality, Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources. liaising closely with other GSK personnel to ensure accuracy of such records.
- Working to agreed deadlines and maintaining records to reflecting project status
- Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice
- CMC experience
- Good written and oral communication and networking skills
- Demonstrate ability to focus and work with attention to detail
- Demonstrate ability to retain critical information
- Be aware of the contents of a marketing authorization application
- Demonstrate team working and effective time management skills
- Be a dynamic and highly motivated individual
- Establish strong relationships and liaise effectively with GSK sites worldwide
- Be proficient in the use of IT packages such as Word and excel.
- Demonstrate problem solving skills
Below description added by Mature Products
Role Specific Requirements
- Post Approval CMC experience
- CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations
- Experience responding to manufacturing site change controls and providing regulatory advice and strategies
- Detailed proven CMC knowledge and experience for EU and EMAP region
- Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Ability to manage multiple project assignments/teams simultaneously and provide data assessment and conclusions
- Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
- Ability to efficiently interact with customers and senior stakeholders as required
- Identifies improvement opportunities for CMC Regulatory processes, policies and systems.
- Good communication skills and flexible approach – “ can do attitude”
- May contribute to process improvement and/or regulatory intelligence projects
Additional Information from Hiring Manager
1 – We need hands on experience in managing change controls in the post approval space (advising on regulatory strategy and authoring) – so not just project management or compiling of documents/publishing etc
2 – we need experience in global markets - so not just EU
3 – we need experience in pharmaceutical CMC regulatory support to include drug substance and drug product- (so not solely generics where experience is weak in drug substance or herbals/cosmetics for example)